From drug development to registration: optimalization of flow processes

Currently, the timeline of drug development, from preclinical over clinical research to ultimately the approval of the drug, takes several years. We will investigate how this process can be optimized to obtain a timely patient access of the new medicine, with a specific interest in immune-mediated inflammatory disorders (IMIDs). We aim to study various phases of drug development including protocol designs (inclusion and exclusion criteria, patient reported outcomes and quality of life), ethical and regulatory approval and patient recruitment, to see where flow processes may be optimized. For authorization of the drug, the European Medicines Agency (EMA) needs to scientifically evaluate the efficacy and safety of the drug. Recently, EMA already implemented changes to its organizational structure to operate as efficiently as possible. Different operations were integrated into one Human Medicine Division and task forces were established to support the division. We want to evaluate if this new formation is adequately used and functioning. We will also explore the process of conditional authorization of medicines and obtaining registration of repurposed medicines.